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Clinical Trials of Artesunate and Artemether against Falciparum Malaria in Chloroquine Resistance Areas : A Preliminary Report (Uji Klinis Artesunat dan Artemeter pada Malaria falsiparum di Daerah Resisten Klorokuin : Laporan Pendahuluan)
At present quinine is the antimalaria drug of choice in the treatment of chloroquine or multidrug resistant malaria and severe or complicated malaria. Artemisinine, a new antimalarial has been reported to be highly effective and of low toxicity. Therefore, artemisinine derivates (artesunate and artemether) need to be evaluated to have an alternative drug to be used in Indonesia. The study has been carried out to assess the efficacy and safety of artesunate and artemether at referal hospitals since 1992. Clinical trials have been performed in adult patients. Uncomplicated falciparum malaria patients were treated with artesunate tablet 600 mg/5 days orally or artemether capsule 480 mg/5 days orally, and severe or complicated falciparum malaria patients were treated with artesunate 240-300 mg/3 days intravenously or artemether 480 mg/5 days intramuscular compared with quinine dihydrochloride loading dose followed with quinine sulfate orally for 7 days. Only artesunate tablet study were presented in this report. The cure rate of artesunate was 100 on D7 (38/38) and D14 (28/28); however on D21 and D28 these were 88.2 percent (15/17) and 75 percent (6/8) because of the presence of late RI cases. The mean fever clearance time and parasite clearance time were as folows 15.1 plus/minus 1.8 hours and 32.1 plus/minus 3.0 hours (D7), 14.1 plus/minus 2.2 hours and 33.3 plus/minus 3.8 hours (D14), 15.7 plus/minus 3.0 hours and 37.6 plus/minus 5.6 hours (D21), 14.0 plus/minus 4.6 hours and 32.0 plus/minus 5.9 hours (D28) respectively. No side effects were found clinically and laboratorilly. Artesunate is effecive and safe for treatment of uncomplicated falciparum malaria until D14 in a chloroquine resistant area. Sequential or combination with other antimalarial drugs should be studied to achieve a radical cure.
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